Prevention of relapse by mesalazine (Pentasa) in pediatric Crohn's disease: a multicenter, double-blind, randomized, placebo-controlled trial
- PMID: 19118966
- DOI: 10.1016/j.gcb.2008.07.007
Prevention of relapse by mesalazine (Pentasa) in pediatric Crohn's disease: a multicenter, double-blind, randomized, placebo-controlled trial
Abstract
Aim: This study aimed to test the efficacy of mesalazine in maintaining remission in pediatric Crohn's disease (CD) following successful flare-up treatment.
Methods: In this double-blind, randomized, placebo-controlled trial, 122 patients received either mesalazine 50mg/kg per day (n=60) or placebo (n=62) for one year. Treatment allocation was stratified according to flare-up treatment (nutrition or medication alone). Recruitment was carried out over two periods, as the first period's results showed a trend favoring mesalazine. Relapse was defined as a Harvey-Bradshaw score more than or equal to 5. Time to relapse was analyzed using the Cox model.
Results: The one-year relapse rate was 57% (n=29) and 63% (n=35) in the mesalazine and placebo groups, respectively. We demonstrated a twofold lower relapse risk (P<0.02) in patients taking mesalazine in the medication stratum (first recruitment period), and a twofold higher risk in patients taking mesalazine in the nutrition stratum (second recruitment period), compared with the other groups. None of the children's characteristics, which differed across the two recruitment periods, accounted for the between-period variation in mesalazine efficacy. One serious adverse event was reported in each treatment group.
Conclusion: Overall, mesalazine does not appear to be an effective maintenance treatment in pediatric CD.
Similar articles
-
[Maintenance treatment of Crohn's disease using orally administered mesalazine (Pentasa). A controlled multicenter study. The Study Groups on the Treatment of Inflammatory Digestive Disorders].Ann Gastroenterol Hepatol (Paris). 1993 Oct;29(5):251-6. Ann Gastroenterol Hepatol (Paris). 1993. PMID: 8250520 Clinical Trial. French.
-
A controlled trial comparing ciprofloxacin with mesalazine for the treatment of active Crohn's disease. Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID).Am J Gastroenterol. 1999 Mar;94(3):674-8. doi: 10.1111/j.1572-0241.1999.935_q.x. Am J Gastroenterol. 1999. PMID: 10086650 Clinical Trial.
-
Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial.Gut. 2010 Jun;59(6):752-9. doi: 10.1136/gut.2009.194159. Gut. 2010. PMID: 20551460 Clinical Trial.
-
Review article: chronic active disease and maintaining remission in Crohn's disease.Aliment Pharmacol Ther. 2004 Oct;20 Suppl 4:102-5. doi: 10.1111/j.1365-2036.2004.02052.x. Aliment Pharmacol Ther. 2004. PMID: 15352904 Review.
-
Oral mesalazine for the treatment of Crohn's disease: clinical efficacy with respect to pharmacokinetic properties.Hepatogastroenterology. 1999 Nov-Dec;46(30):3124-35. Hepatogastroenterology. 1999. PMID: 10626173 Review.
Cited by
-
Current therapy of pediatric Crohn's disease.World J Gastrointest Pathophysiol. 2015 May 15;6(2):33-42. doi: 10.4291/wjgp.v6.i2.33. World J Gastrointest Pathophysiol. 2015. PMID: 25977836 Free PMC article. Review.
-
Clinical course of new-onset Crohn's disease in children and adolescents in dependency of age, initial location, initial severity level and therapy over the period 2000-2014 based on the Saxon Pediatric IBD-Registry in Germany.PLoS One. 2023 Jun 29;18(6):e0287860. doi: 10.1371/journal.pone.0287860. eCollection 2023. PLoS One. 2023. PMID: 37384664 Free PMC article.
-
Biologics in paediatric Crohn's disease.Gastroenterol Res Pract. 2011;2011:287574. doi: 10.1155/2011/287574. Epub 2011 Nov 17. Gastroenterol Res Pract. 2011. PMID: 22144993 Free PMC article.
-
Inflammatory Bowel Disease in Children.Indian J Pediatr. 2024 May;91(5):490-498. doi: 10.1007/s12098-023-04671-0. Epub 2023 Jun 20. Indian J Pediatr. 2024. PMID: 37338669 Review.
-
Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease.Cochrane Database Syst Rev. 2016 Sep 28;9(9):CD003715. doi: 10.1002/14651858.CD003715.pub3. Cochrane Database Syst Rev. 2016. PMID: 27681657 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical